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New plug device under study for aneurysms and other blood flow problems

NCT ID NCT06099015

Disease control Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking how well a device called the Cera Vascular Plug works and if it is safe. The plug is used to block blood flow in certain blood vessels to treat conditions like aneurysms, abnormal connections between arteries and veins, and other problems. About 132 adults who need this type of treatment will be enrolled and followed to see if the plug works right away and if any side effects occur over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who need arterial or venous embolization in the peripheral vasculature.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 to 85; 2. Life expectancy \> 1 year; 3. Require arterial or venous embolization in the peripheral vasculature; 4. Target embolization site(s) allow for safe insertion of the delivery catheter; 5. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement; 6. Willing and able to comply with protocol requirements, including all study visits and procedures. 7. Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study. Exclusion Criteria: 1. The subject is pregnant or plan to be pregnant or breast feeding; 2. The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride; 3. The subject has a known allergy or hypersensitivity to contrast agent; 4. The subject has uncorrectable coagulopathy; 5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints 6. The subject has an unresolved systemic infection; 7. Subject who cannot tolerate general or local anesthesia; 8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder; 9. The subject is participating in other drug or medical device clinical trials; 10. Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

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Conditions

The condition(s) this trial relates to.

Aneurysm arteriovenous hemangioma/malformation congenital arteriovenous fistula Endoleak portal hypertension Pulmonary Arteriovenous Fistulas

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm Arteriovenous fistula Endoleak Portal hypertension Pulmonary arteriovenous malformation Splenic laceration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Città della Salute e Della Scienza di Torino

    RECRUITING

    Turin, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Italy

  • Adana City Hospital

    RECRUITING

    Adana, Turkey (Türkiye)

  • Ankara University Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Bilkent City Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Bilkent City Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Italy

  • Klinikum Bad Hersfeld GmbH

    RECRUITING

    Bad Hersfeld, Germany

  • Ospedale di Circolo

    RECRUITING

    Varese, Italy

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